Method and apparatus for facilitating injection of medication into an intravenous fluid line while maintaining sterility of infused fluids

ABSTRACT

A warming device for an IV fluid line according to the present invention includes a warmer unit and a wye type fitting with an injection site. The warmer unit includes a tube for intravenous fluid and channels containing a warming fluid to heat the IV tube. One fitting branch is connected to an intravenous fluid source, while the remaining branch houses the injection site. The injection site branch includes an injection safety member that ensures a syringe needle or other instrument is contained within the fitting to prevent rupture of the IV tube. The warming device may include an additional wye type fitting coupled to the initial fitting and including another injection site, where the fittings typically exclude the safety member. A syringe needle is inserted into the additional injection site to prevent rupture of the IV tube. In addition, the warming device may be configured for needleless injections.

BACKGROUND OF THE INVENTION

1. Technical Field

The present invention pertains to infusion devices that enable injectionof fluids into an intravenous fluid line during infusion of intravenoussolution into a patient. In particular, the present invention isdirected toward an infusion warming device for warming infused fluidswithin a fluid line and including an injection site to facilitateinjection of medicaments into the fluid line without compromisinginfused fluid sterility.

2. Discussion of Related Art

Intravenous (IV) fluids are typically infused into a patient utilizing aliquid-filled bag or container and an IV fluid line. The fluids aregenerally delivered from the container to the patient via gravitationalforces and/or applied pressure. It is important in many situations thatthe temperature of the intravenous fluid be maintained within adesirable and safe temperature range upon entering the patient body soas to eliminate any potential for thermal shock and injury to thepatient.

Accordingly, the related art provides various devices for controllingthe temperature of fluid in an IV line for infusion into a patient. Onesuch device employs a heat exchanger to heat and maintain fluid flowingwithin an IV line at a desired temperature. For example, U.S. Pat. No.5,063,994 (Verkaart) discloses a heat exchanger including a central tubefor carrying an infusate and two outer channels for carrying a heatexchange fluid. A first channel carries the heat exchange fluid from aninlet end to an opposite end, while a second channel returns the fluidto the inlet end. An end cap at the inlet end is connected to a sourceof heat exchange fluid and communicates with the channels. An end cap atthe opposite end receives the heat exchange fluid from the first channeland re-directs the fluid to the second channel. The end caps haveconnectors for facilitating connection with lines from an infusatesource and a patient.

In addition, it may be beneficial or required in certain situations toadminister medications or medicaments in combination with IV fluids viathe fluid line. Although the Verkaart device warms fluid, there is noprovision for enabling administration of medicaments within the fluid.The related art has attempted to overcome this problem by providinginfusion warming devices enabling injection of medicaments into an IVline. This is typically accomplished by inserting a syringe needle intoa line injection site. For example, the HOTLINE device, available fromSIMS Level 1, Inc., includes a heat exchanger employing a layer ofcirculating warm water surrounding an IV line in order to heatintravenous fluid flowing therein. The device further includes aninjection site for receiving a syringe needle. The injection siteincludes a membrane or seal to accommodate insertion and removal of thesyringe needle within that site.

However, this type of device suffers from several disadvantages. Inparticular, the injection site generally enables syringe needles tocompromise intravenous fluid sterility. Specifically, a syringe needlemay be inserted within and extend through the injection site, therebycontacting and inadvertently puncturing the IV line. This results inmixing of IV fluid with the surrounding warm water and compromises IVfluid sterility. As a consequence, the patient may suffer adverseaffects, including infections and/or illness. In addition, thenon-sterile conditions may compromise performance of a medical procedureand/or facilitate extended hospital stays for the patient, therebysubstantially increasing medical costs.

OBJECTS AND SUMMARY OF THE INVENTION

Accordingly, it is an object of the present invention to facilitateinjection of medicaments into an IV line without comprising sterility ofIV fluid flowing therein.

It is another object of the present invention to facilitate injection ofmedicaments into an IV line without compromising IV fluid sterility byconfiguring an injection site of a line warming device to preventpuncturing of the IV line by a syringe needle during an injection.

Yet another object of the present invention is to facilitate injectionof medicaments into an IV line without compromising IV fluid sterilityby employing a needleless injection site with an IV line warming device.

The aforesaid objects may be achieved individually and/or incombination, and it is not intended that the present invention beconstrued as requiring two or more of the objects to be combined unlessexpressly required by the claims attached hereto.

According to the present invention, a warming device for an IV fluidline includes a warmer or heat transfer unit and a fitting including aninjection site to receive a syringe needle. The warmer unit includes atube for intravenous (IV) fluid and channels encompassing the tube forcontaining a warming or heat transfer fluid to heat the IV fluid tube. Afirst channel directs the heat transfer fluid along the IV tube and awayfrom a heat transfer fluid inlet, while a second channel directs theheat transfer fluid back toward the inlet to a heat transfer fluidoutlet. An end cap at the warmer unit proximal end is connected to asource of heat transfer fluid, while another end cap at the warmer unitdistal end directs the heat transfer fluid from the first channel to thesecond channel.

The proximal and distal end caps are coupled to the fitting and a lineto a patient, respectively. The fitting is attached to the proximal endcap and includes a wye type configuration. One fitting branch isconnected to an intravenous fluid source, while the remaining branchhouses the injection site. The injection site branch includes aninjection safety member that ensures a syringe needle or otherinstrument is properly contained within the fitting to prevent ruptureof the IV tube and contamination of intravenous fluid flowing therein.The warming device may alternatively include an additional wye typefitting. The additional fitting is coupled to the initial warming devicefitting and includes another injection site. The warming device fittingstypically exclude the injection safety member, where a syringe needle isinserted into the additional fitting injection site to prevent ruptureof the IV tube by the syringe needle.

In addition, the warming device may be configured for needlelessinjections. Specifically, an injection site branch of the warming devicefitting includes a connection member in the form of a female Luerconnector. The connection member enables engagement of the fitting witha needleless connector that facilitates needleless injections into theIV line, thereby preventing rupture of the IV tube.

The above and still further objects, features and advantages of thepresent invention will become apparent upon consideration of thefollowing detailed description of specific embodiments thereof,particularly when taken in conjunction with the accompanying drawings,wherein like reference numerals in the various figures are utilized todesignate like components.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view in partial section of a warming deviceattached to an IV line and including an injection site configured tomaintain fluid sterility during injections according to the presentinvention.

FIG. 2 is a view in elevation and section of the warming device of FIG.1 taken along lines II-II.

FIG. 3 is a view in partial section of a distal end cap of the warmingdevice of FIG. 1 taken along lines III-III.

FIG. 4 is a view in partial section of a proximal end cap of the warmingdevice of FIG. 1 taken along lines IV-IV.

FIG. 5 is a perspective view in partial section of a warming deviceemploying an additional fitting to maintain fluid sterility duringinjections according to the present invention.

FIG. 6 is an exploded perspective view in partial section of a warmingdevice configured for needleless injections according to the presentinvention

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

A warming device or system according to the present invention formaintaining IV fluids flowing within an IV line at a selectedtemperature and ensuring sterility of the fluids during injections isillustrated in FIGS. 1-2. Specifically, warming system 1 includes a heattransfer or warmer unit 4 and a wye type fitting 20 that includes aninjection site 59 for receiving a syringe needle or other instrument.Warmer unit 4 includes a generally cylindrical IV tube 8 disposed withina generally cylindrical heat transfer tube 6. The tubes are disposed ina substantially concentric fashion with IV tube 8 extendinglongitudinally for substantially the entire length of heat transfer tube6. A distal end cap 10 is attached to a distal end of heat transfer tube6 and connects in a suitable manner, via a male Luer fitting orconnector 47, to an IV line portion 11 that extends to an infusion site(not shown) on a patient body (e.g., arm or other suitable location).

The area between IV tube 8 and heat transfer tube 6 receives a warmingor heat transfer fluid, while IV tube 8 contains intravenous fluid forthe patient. The heat transfer fluid flows within the area to heat theintravenous fluid flowing within tube 8. Walls 32, 34 extend between theIV and heat transfer tubes and are angularly displaced from each otherby approximately one-hundred eighty degrees relative to the IV tube. Thewalls partition the area into channels 36, 38 for containing the heattransfer fluid. Channel 36 directs the heat transfer fluid distallyalong tube 8 and away from a heat transfer fluid inlet 13, while channel38 directs the fluid proximally along the IV tube to a heat transferfluid outlet 14. The fluid in channel 36 is directed into channel 38 viadistal end cap 10 secured to the distal ends of tubes 6, 8. Inlet 13 andoutlet 14 are each connected to a heat transfer fluid supply source (notshown) that maintains the heat exchange fluid at a particulartemperature. For an example of a type of heated fluid source that may beutilized with the present invention, reference is made to U.S. Pat. No.4,759,749 (Verkaart), the disclosure of which is incorporated herein byreference in its entirety.

Referring to FIG. 3, distal end cap 10 includes a generally cylindricaltube engagement member 42, a generally cylindrical connector member 44and a conduit 46. Engagement member 42 engages the outer surface of heattransfer tube 6. Conduit 46 is defined in the engagement member bottomwall and tapers in dimension therefrom to be received in IV tube 8. MaleLuer fitting 47 (FIG. 1) includes a projection 48 that is received inconnector member 44, thereby placing the Luer fitting in fluidcommunication with conduit 46. The area between conduit 46 andengagement member 42 forms a chamber 50 for redirecting heat transferfluid from channel 36 into channel 38. The Luer fitting is connected toline portion 11 (FIG. 1) and enables delivery of heated IV fluid fromwarmer unit 4 to the patient.

Referring to FIG. 4, a proximal end cap 12, similar to end cap 10, isdisposed toward the warmer unit proximal end. Specifically, the proximalend cap includes a generally cylindrical tube engagement member 52, agenerally cylindrical connector member 53 (FIG. 1) and a conduit 54 eachsubstantially similar to the corresponding components described abovefor end cap 10. Engagement member 52 engages the outer surface of heattransfer tube 6. Conduit 54 is defined in an engagement member bottomwall and tapers in dimension therefrom to be received in IV tube 8 asdescribed above. End cap 12 further includes walls 60, 62 that arealigned with walls 32, 34 of heat transfer tube 6 to enable fluid toflow between end cap 12 and appropriate channels 36, 38. Walls 60, 62basically partition the area between engagement member 52 and conduit 54to form inlet and outlet chambers 64, 66 that align with channels 36,38. In other words, walls 60, 62 isolate fluid flowing within theproximal end cap and channels and enable fluid from channel 38 to enteroutlet 14 and fluid from inlet 13 to enter channel 36. End cap 12further includes inlet 13 and outlet 14 extending transversely therefromto connect with a heat transfer fluid supply source (not shown). Theheat transfer fluid enters the warmer unit via inlet 13 and travelswithin channel 36 to distal end cap 10 and returns via channel 38 toexit the warmer unit via outlet 14. A continuous supply of heat transferfluid is delivered from the fluid supply source to the warmer unit tosurround and heat fluid within IV tube 8, while the warmer unitconfiguration maintains separation between the transfer and IV fluidflowing within heat transfer tube 6. For an example of the structure andoperation of this type of warmer unit, reference is made to U.S. Pat.No. 5,063,994 (Verkaart), the disclosure of which is incorporated hereinby reference in its entirety.

Referring back to FIG. 1, warming device 1 includes wye type fitting 20attached to the proximal end of end cap 12 and in fluid communicationwith conduit 54. The fitting includes a generally cylindrical base 70with a substantially cylindrical projection 72 and an injection safetymember 56. The projection extends from a base distal portion and istypically oriented at an approximate forty-five degree angle relative toa base longitudinal axis. An IV line portion 28 is connected to theprojection and typically extends to an IV fluid source. A female Luerconnector 76 is typically disposed at the line portion proximal end tofacilitate connection of the line to the source.

The base proximal portion includes injection site 59 to enable injectionof medicaments or other fluids into the IV line. The injection siteresides at the proximal end of the base and preferably includes amembrane 58 to seal the base proximal end and maintain fluids within thefitting. The membrane further enables insertion and removal of a syringeneedle within the fitting for injection of medicaments. The membrane maybe implemented by a cap or plug that maintains a fluid tight seal andpermits removable insertion of the syringe needle. For an example of thestructure and operation of a fitting injection site, reference is madeto U.S. Pat. No. 4,585,435 (Vaillancourt), the disclosure of which isincorporated herein by reference in its entirety. Since syringestypically include needles having maximum length dimensions in theapproximate range of 2.5 to 3.0 inches, the needles tend to extendbeyond of the confines of the base (e.g., typically including a lengthdimension of approximately two inches) and contact and rupture IV tube8. This enables the IV fluid to mix with the non-sterile heat transferfluid, thereby compromising sterility of the IV fluid and/orcontaminating a medical procedure. In order to ensure sterility of theIV fluid during injections, base 70 includes injection safety member 56disposed at the proximal end of the injection site. The safety member issubstantially cylindrical and includes an open proximal end and a hollowinterior to receive a syringe needle or other medical instrument. Thesafety member width dimensions are similar to those of base 70 (e.g.,less than those of a syringe body but greater than those of a syringeneedle), while the safety member length dimensions provide the fittingwith a length greater than that of the syringe needle. By way of exampleonly, the safety member may include a length in the approximate range of0.5 to 1.0 inches. The safety member basically serves as a stop to limitsyringe needle insertion and prevent contact between the needle and IVtube 8. In other words, the safety member includes width and lengthdimensions sufficient to maintain the syringe needle within fitting 20.The syringe may contain and inject any medicaments or other fluids intothe fitting to mix with IV fluid. The safety member may be attached tothe base injection site branch via any suitable connectors or be formedintegral with that branch. Alternatively, the base injection site branchmay include elongated dimensions sufficient to maintain the syringeneedle within the fitting as described above, or may include membrane 58disposed at the proximal end of the safety member.

In operation, IV fluid is directed from an IV fluid source through IVline portion 28 to projection 72 of wye fitting 20. The IV fluidcontinues traveling through the fitting emerging at the base distal endand passing through end cap 12 into IV tube 8 of warmer unit 4. Heattransfer fluid is continuously circulated through the warmer unit viainlet 13, outlet 14, and channels 36, 38 as described above. The heattransfer fluid basically flows from a heat transfer fluid supply sourceand through warmer unit 4 to surround IV tube 8 and heat IV fluidflowing therein. The IV fluid passes through the IV tube and exits thewarmer unit through distal end cap 10 into IV line portion 11 thatextends to the infusion site. At any time during system operation, asyringe needle may be inserted into membrane 58 of fitting 20 to injectappropriate medicaments into the IV line. The medicaments mix with theIV fluid flowing within fitting 20 and toward the infusion site asdescribed above. The safety member retains the syringe needle within thefitting to prevent the needle from contacting and rupturing the IV tube,thereby ensuring sterility of the IV fluid during injections.

An alternative embodiment of the warming device of the present inventionis illustrated in FIG. 5. Specifically, device 2 includes a warmer unit4 and a fitting assembly 30. The warmer unit is substantially similar tothe warmer unit described above and includes IV tube 8 disposed withinheat transfer tube 6 and distal and proximal end caps 10, 12. The areabetween the IV and heat transfer tubes receives a warming or heattransfer fluid, while IV tube 8 contains intravenous fluid for thepatient as described above. The IV and heat transfer tubes are connectedby walls that partition the area into channels for directing heattransfer fluid flow through the warmer unit in substantially the samemanner described above. End cap 10 disposed at the warmer unit distalend is coupled to IV line portion 11 extending to the patient. Distalend cap 10 enables IV fluid to flow from IV tube 8 to IV line portion 11and directs heat transfer fluid between the warmer unit channels asdescribed above. Proximal end cap 12 is disposed at the warmer unitproximal end and includes fluid inlet 13 and fluid outlet 14. Theproximal end cap facilitates flow of heat transfer fluid to and from aheated fluid supply source and through the appropriate channels asdescribed above. The proximal end cap further enables IV fluid to flowinto the IV tube as described above.

Fitting assembly 30 includes wye type fittings 45, 49 in fluidcommunication with each other to facilitate delivery of IV fluid from asource to the warmer unit. Fitting 45 is similar to fitting 20 describedabove and includes a generally cylindrical base 55 with substantiallycylindrical projection 57. The projection extends from a base distalportion and is typically oriented at an approximate forty-five degreeangle relative to a base longitudinal axis. The projection is connectedto an IV line portion 25 that extends to wye type fitting 49. The baseproximal portion includes injection site 59 to enable injection ofmedicaments or other fluids into the IV line. The injection site issubstantially similar to the injection site described above and includesmembrane 58 to seal the base proximal end and maintain fluids within thefitting. The membrane further enables insertion and removal of a syringeneedle within the fitting for injection of medicaments.

As described above, syringes typically include needles having dimensionsthat enable the needle to extend beyond the base confines and contactand rupture IV tube 8, thereby compromising sterility of the IV fluidand/or contaminating a medical procedure. In order to ensure sterilityof the IV fluid, wye type fitting 49 is employed to serve as theinjection site and displace the syringe needle from the IV tube.Specifically, wye type fitting 49 is substantially similar to fitting 45and includes base 55 and projection 57 each as described above. The baseportion distal end is attached to IV line portion 25, while the proximalend includes an injection site 59 with membrane 58 as described above.The membrane basically seals the base proximal end and maintains fluidswithin the fitting. The membrane further enables insertion and removalof a syringe needle within the fitting for injection of medicaments asdescribed above. The projection of fitting 49 is connected to an IV lineportion 28 that extends to an IV fluid source. Female Luer connector 76is typically disposed at the line portion proximal end to facilitateconnection of the line to the source. Thus, IV fluid from the sourceflows through fittings 49 and 45 and warmer unit 4 to the patient.Medicaments are injected into the IV line via injection site 59 offitting 49 in order to prevent the syringe needle from contacting andrupturing IV tube 8. Further, fitting 49 may be placed at any suitablelocation along the line to prevent rupture of the IV tube.Alternatively, fitting 45 may be utilized without fitting 49 and may beplaced at any suitable location along the IV line to prevent a syringeneedle from contacting and rupturing IV line 8. The warming unit andfittings may be connected in any fashion, or may be formed as anintegral device for infusion of fluids.

In operation, IV fluid is directed from an IV fluid source through IVline portion 28 to projection 57 of fitting 49. The IV fluid flowsthrough fitting 49 and into IV line portion 25 from the fitting base.Projection 57 of fitting 45 directs the IV fluid through proximal endcap 12 into IV tube 8. Heat transfer fluid is continuously circulatedthrough warmer unit 4 to heat the IV fluid flowing in IV tube 8 asdescribed above. The IV fluid passes through the IV tube and exits thewarmer unit through distal end cap 10 into IV line portion 11 thatextends to the infusion site. A syringe needle is preferably insertedinto injection site 59 of fitting 49 to inject appropriate medicamentsinto the IV line. The medicaments mix with the IV fluid flowing withinfitting 49 and flow through fitting 45 and warmer unit 4 toward theinfusion site as described above. The displacement of the injection sitewithin fitting 49 prevents the syringe needle from contacting andrupturing IV tube 8, thereby maintaining sterility of the IV fluid.

The warming device may further be configured to accommodate needlelessinjections as illustrated in FIG. 6. Specifically, device 3 includes awarmer unit 4 and a fitting 21. The warmer unit is substantially similarto the warmer unit described above and includes an IV tube 8 disposedwithin heat transfer tube 6 and distal and proximal end caps 10, 12. Thearea between the IV and heat transfer tubes receives a warming or heattransfer fluid, while IV tube 8 contains intravenous fluid for thepatient as described above. The IV and heat transfer tubes are connectedby walls that partition the area into channels for directing heattransfer fluid flow through the warmer unit in substantially the samemanner described above. Distal end cap 10 disposed at the warmer unitdistal end is coupled to IV line portion 11 extending to the patient.The distal end cap enables IV fluid to flow from IV tube 8 to IV lineportion 11 and directs heat transfer fluid between the channels asdescribed above. Proximal end cap 12 is disposed at the warmer unitproximal end and includes heat transfer fluid inlet 13 and outlet 14.The proximal end cap facilitates flow of heat transfer fluid to and froma heated fluid supply source and through the appropriate channels asdescribed above. The proximal end cap further enables IV fluid to flowinto the IV tube from fitting 21 as described above.

Fitting 21 is similar to fitting 20 described above for FIG. 1 andincludes generally cylindrical base 70 with a substantially cylindricalprojection 72. The projection extends from a base distal portion and istypically oriented at an approximate forty-five degree angle relative toa base longitudinal axis. The projection is connected to IV line portion28 that extends to an IV fluid source. The line portion typicallyincludes female Luer connector 76 disposed at the line proximal end tofacilitate connection of the line to the fluid source. The base proximalportion includes injection site 59 to enable injection of medicaments orother fluids into the IV line. The injection site is similar to theinjection site described above and includes membrane 58 to seal the baseproximal end and maintain fluids within the fitting.

As described above, syringes typically include needles that may contactand rupture IV tube 8, thereby compromising sterility of the IV fluidand/or contaminating a medical procedure. In order to ensure sterilityof the IV fluid, fitting 21 is configured to accommodate a needlelessconnector 82 in order to facilitate needleless injections. Inparticular, base 70 includes a connection member 74 extending proximallyfrom membrane 58 of injection site 59. The connection member issubstantially cylindrical with a hollow interior and substantially thesame width dimension as base 70. The connection member is configured inthe form of a female Luer connector and includes fins 78 angularlyspaced apart by approximately one-hundred eighty degrees to facilitateconnection with needleless connector 82. Basically, needleless connector82 includes a seal or valve mechanism to enable entry and flow of fluidtherethrough from an instrument 79. The instrument is preferably aconventional syringe without a needle containing a medicament or otherfluid and including a substantially blunt distal end projection 80serving as a fluid outlet. The blunt projection generally includes aseal to maintain the fluid in the instrument. Connector 82 furtherincludes a proximal entry site 84 for receiving instrument 79 and adistal end 86 preferably in the form of a male Luer connector forengagement with the female Luer configuration of connection member 74.

The instrument projection is inserted into the needleless connector tofacilitate an injection. This penetrates the instrument distal end sealand further enables the needleless connector valve or seal mechanism topermit fluid to flow from the instrument and through the needlelessconnector. The fluid flows from the needleless connector throughmembrane 58 and mixes with the IV fluid in base 70. The mixturesubsequently flows through warmer unit 4 and to the patient as describedabove. Removal of the instrument permits the instrument seal to closeand disables the valve, thereby maintaining the intravenous fluid andmedicament in the fitting and instrument, respectively. The needlelessconnector may be implemented by any conventional needleless connector,such as the KippMed Needleless Access Connector available from PorexMedical Products, Inc. of Ontario, Calif. For further examples ofneedleless connectors and systems, reference is made to U.S. Pat. Nos.5,573,516 (Tyner), 6,146,362 (Turnbull et al.) and 6,344,033 (Jepson etal.), the disclosures of which are incorporated herein by reference intheir entireties.

In operation, needleless connector 82 is attached to connector member74. IV fluid is directed from an IV fluid source through IV line portion28 to projection 72 of fitting 21. The IV fluid continues travelingthrough the fitting emerging at the base distal end and passing throughproximal end cap 12 into IV tube 8 of warmer unit 4. Heat transfer fluidis continuously circulated through the warmer unit via inlet 13, outlet14 and channels 36, 38 as described above. The fluid flows from a heattransfer fluid supply source and through warmer unit 4 to surround IVtube 8 and heat fluid flowing therein. The IV fluid passes through theIV tube and exits the warmer unit through distal end cap 10 into IV lineportion 11 that extends to the infusion site. Medical instrument 79containing a medicament or other fluid may be inserted into needlelessconnector 82 to inject medicaments into the IV line. The instrumentdistal end is received in the needleless connector to enable medicationto flow from the instrument through the needleless connector and intothe fitting. The medication mixes with the IV fluid flowing withinfitting 21 and flows toward the infusion site as described above. Theneedleless connector facilitates needleless injection of the medicationinto the IV line, thereby preventing rupturing of the IV tube.

It will be appreciated that the embodiments described above andillustrated in the drawings represent only a few of the many ways ofimplementing a method and apparatus for facilitating injection ofmedication into an intravenous fluid line while maintaining sterility ofinfused fluids.

The warmer unit of the systems may be of any shape, size and/orconfiguration, and may be constructed of any suitable materials. Thewarmer unit may control the temperature of IV or other fluid flowingwithin the fluid line to any desired temperature or temperature ranges.The systems may include any quantity of warmer units disposed at anylocations along the fluid line to heat the fluid. The systems may beutilized with any type of infused or other fluid (e.g., IV, saline,blood, drugs, etc.) from any desired fluid supply source (e.g., bag,container, pump, etc.). The systems may alternatively utilize any typeof heat transfer system employing heat transfer fluid for maintaining IVfluids flowing within an IV line at selected temperatures. The warmingsystems may include any suitable configuration and may include anynumber of fittings, piping conduits, extension pieces, or othercomponents arranged in any suitable orientation and order with respectto each other for providing a fluid flow path between a fluid supplysource and the warmer unit.

The warmer unit may include any quantity of fluid lines coupled to theunit in any desired fashion. The lines may be of any size or shape andmay be coupled to the unit or end caps via any conventional or otherconnectors. The heat transfer and IV tubes and end caps of the warmerunit may be of any shape or size and may be constructed of any desiredmaterials. The tubes may be nested or arranged in any desired fashion.The heat transfer tube may include or be partitioned into any quantityof channels or passages of any shape or size to direct heat transferfluid in any desired direction. The channels may be disposed within theheat transfer tube at any locations and in any manner. The heat transferfluid may be implemented by any fluid capable of heating the IV tube andfluid flowing therein (e.g., water or other liquid, gas, etc.).

The end caps may be of any quantity, shape or size and disposed at anysuitable locations. The end cap components (e.g., members, conduit,projection, etc.) may be of any quantity, shape or size, may beconstructed of any suitable materials and may be arranged or disposed inany fashion. The end caps may include any conventional or otherconnectors to couple to the fluid line or fitting. The end caps maydirect fluid within or into the warming unit in any desired fashion. Theend cap walls and chambers may be of any quantity, shape or size, andmay be disposed at any location or arranged in any fashion. The heattransfer fluid inlet and outlet may be of any quantity, shape or sizeand may be disposed at any suitable locations. The heat transfer fluidmay be supplied by any suitable source and may be directed through thewarmer unit continuously or at any desired intervals or rates to heatthe intravenous fluid.

The fittings of the warming devices may be of any quantity, shape orsize and may be disposed at any suitable locations with respect to thewarmer unit or fluid line. The fittings may be implemented by any typesof fittings including any configuration (e.g., tee fittings, crossfittings, elbows, couplings and any combinations thereof, etc.). Thefitting components (e.g., base, projection, injection safety member,injection site, etc.) may be of any quantity, shape or size, may beconstructed of any suitable materials (e.g., plastic, etc.) and may bedisposed at any suitable locations or arranged in any fashion. Theprojection of the fittings may be oriented at any desired angle relativeto the corresponding projection base.

The injection site of the fittings may be of any quantity, shape orsize, may be constructed of any desired materials and may be disposed atany suitable locations with respect to the fitting and fluid line. Theinjection site membrane may be of any quantity, shape or size, may bedisposed at any location within the fittings and may be constructed ofrubber or any other suitable material. The membrane may be configured asa plug, end cap or any other suitable device capable of sealing anopening at any suitable locations along the fluid line, while permittinga syringe needle or other instrument to be removably inserted throughthe membrane. The injection safety member may be of any quantity, shapeor size, may be constructed of any suitable materials, and may bedisposed at any location on the fittings. The injection safety membermay accommodate any type of instrument at any location for injection ofmedication or other fluids (e.g., syringe, etc.) and may be configuredin any manner (e.g., partially or fully open end, partially or fullyclosed end, openings at any locations, etc.) to receive the instrument.The injection safety member may include any desired length and widthdimensions to prevent needles or instruments from rupturing the IV tube.The safety member may be attached to the injection site branch of afitting via any suitable connectors or be formed integral with thatbranch. Alternatively, the fitting injection site branch may includeelongated dimensions sufficient to maintain the syringe needle withinthe fitting, or may include a membrane or other cover or seal disposedat the proximal end of the safety member. The injection sites mayaccommodate injection of any types of fluids (e.g., medication, drugs,etc.).

The fitting assembly of the plural fitting embodiment may include anyquantity of fittings of any shape or size, disposed at any suitablelocations and coupled in any desired fashion. The fittings may be of anyquantity, shape or size and may be disposed at any suitable locationswith respect to the warmer unit or fluid line. The fittings may beimplemented by any types of fittings including any configuration (e.g.,tee fittings, cross fittings, elbows, couplings and any combinationsthereof, etc.). The fitting components (e.g., base, projection,injection site, etc.) may be of any quantity, shape or size, may beconstructed of any suitable materials (e.g., plastic, etc.) and may bedisposed at any suitable locations or arranged in any fashion. Theprojection of the fittings may be oriented at any desired angle relativeto the corresponding projection base. The injection site of the fittingsmay be of any quantity, shape or size, may be constructed of any desiredmaterials and may be disposed at any suitable locations with respect tothe fitting and fluid line. The membranes of the injection sites may beof any quantity, shape or size, may be disposed at any location withinthe fittings and may be constructed of rubber or any other suitablematerial. The membranes may be configured as a plug, end cap or anyother suitable device capable of sealing an opening at any suitablelocations along the fluid line, while permitting a syringe needle orother instrument to be removably inserted through the membrane. Thefittings may optionally include the injection safety member describedabove. The fitting assembly may be disposed at any suitable locationalong the fluid line, and any quantity of injection sites may includethe injection safety member and/or be utilized to accommodateinjections.

The warming devices may include any quantity of any conventional orother connectors or fasteners to couple the warmer unit, lines, tubes,fittings and fluid supply sources in any fashion. The warming devicecomponents (e.g., warmer unit, fittings, etc.) may be formed integral asa single unit or be attached together in any desired fashion (e.g.,connectors, welded, etc.).

The needleless warming device fitting may be of any quantity, shape orsize and may be disposed at any suitable locations with respect to thewarmer unit or fluid line. The fitting may be implemented by any typesof fittings including any configuration (e.g., tee fittings, crossfittings, elbows, couplings and any combinations thereof, etc.). Thefitting components (e.g., base, projection, injection site, etc.) may beof any quantity, shape or size, may be constructed of any suitablematerials (e.g., plastic, etc.) and may be disposed at any suitablelocations or arranged in any fashion. The projection of the fitting maybe oriented at any desired angle relative to the projection base. Theinjection site of the fitting may be of any quantity, shape or size, maybe constructed of any desired materials and may be disposed at anysuitable locations with respect to the fitting and fluid line. Theinjection site membrane may be of any quantity, shape or size, may bedisposed at any location within the fitting and may be constructed ofrubber or any other suitable material. The membrane may be configured asa plug, end cap or any other suitable device. The fitting projection maybe configured or include any type of connector for engagement with aneedleless connector. The needleless connector may be implemented by anyconventional or other connector facilitating needless injections, andmay include any type of connector for engagement with the projection.The fitting connector may include any quantity of fins or otherprojections of any shape or size to engage the needleless connector. Theneedless connector may accommodate any needleless syringe or any otherinstrument containing fluid for injection into the fluid line. Thefitting may optionally function without the membrane and rely on theneedleless connector to seal the fitting.

The systems may be utilized individually or be combined in any desiredfashion. For example, the plural fitting embodiment may utilize any ofthe fittings of the other devices (e.g., needleless fitting, fittingwith safety member, etc.). Further, any quantity of the devices in anydesired combination may be utilized along a fluid line. In addition, thesystems (e.g., safety member, plural fitting, needleless, etc.) may beutilized to prevent contact and rupture of any or each of the tubes(e.g., tube carrying intravenous fluid, tube or channels carrying heattransfer fluid, etc.).

It is to be understood that the terms “top”, “bottom”, “length”,“width”, “upper”, “lower”, “horizontal”, “vertical”, “side” and the likeare used herein merely to describe points of reference and do not limitthe present invention to any specific configuration or orientation.

From the foregoing description, it will be appreciated that theinvention makes available a novel method and apparatus for facilitatinginjection of medication into an intravenous fluid line while maintainingsterility of infused fluids, wherein an injection site of an infusedfluid warming device is configured to prevent rupture of a device IVfluid line during injections of medication into the infused fluid.

Having described preferred embodiments of a new and improved method andapparatus for facilitating injection of medication into an intravenousfluid line while maintaining sterility of infused fluids, it is believedthat other modifications, variations and changes will be suggested tothose skilled in the art in view of the teachings set forth herein. Itis therefore to be understood that all such variations, modificationsand changes are believed to fall within the scope of the presentinvention as defined by the appended claims.

1. An infusion system to deliver intravenous fluid from a supply sourceto an infusion site via a fluid line and to enable injection ofmedicinal fluid into said fluid line while maintaining sterility of saidintravenous fluid, said system comprising: a heat transfer unitincluding first and second conduits, wherein said first conduit receivessaid intravenous fluid and is connected with a fluid line portionextending toward said infusion site and said second conduit receivesheat transfer fluid to heat said intravenous fluid flowing through saidfirst conduit; and a fluid connector assembly to facilitate fluid flowbetween said supply source and said heat transfer unit and including: afitting including a housing structure to receive said intravenous fluidand to direct said intravenous fluid received by said fitting into saidheat transfer unit, wherein said housing structure includes: anelongated tubular body including a proximal end portion; a fluid inletmember with a distal end directly attached to said elongated tubularbody and a proximal end to receive intravenous fluid into said housingstructure; and a fluid outlet disposed at a distal end of said elongatedtubular body and secured to said heat transfer unit with said fluidoutlet in fluid communication with said first conduit; wherein saidproximal end portion of said elongated tubular body includes: aninstrument member positioned within a proximal portion of said elongatedtubular body, wherein said instrument member includes a membrane tomaintain a fluid tight seal and permit removable insertion of a portionof an instrument through said membrane and within said fluid connectorassembly, wherein said instrument includes a syringe containing amedicinal fluid and said instrument portion includes a needle with alength dimension, and wherein said syringe facilitates injection of amedicinal fluid different than said intravenous fluid into said fluidconnector assembly; and an extension member extending proximally fromsaid instrument member and forming a proximal end of said elongatedtubular body, wherein said extension member is configured to engage asyringe distal portion and enable insertion of said needle within saidextension member, and wherein said extension member is configured todisplace said syringe from said instrument member and provide a distancefrom said conduits greater than said length dimension of said needle toprevent contact and rupture of said conduits by said needle during saidinjection.
 2. The system of claim 1, wherein said extension member isdisposed proximate said membrane and configured to engage said syringedistal portion and displace that portion from said membrane to restrictinsertion of said needle into said fluid connector assembly.
 3. Thesystem of claim 2, wherein said extension member includes a lengthdimension in the approximate range of 0.5 to 1.0 inches to distance saidneedle from said conduits and restrict insertion of said needle intosaid instrument member.
 4. The system of claim 1, wherein said fluidconnector assembly further includes: a second fitting including: adistal end in fluid communication with said fluid inlet member; a secondfluid inlet member disposed at a proximal end of said second fitting toreceive said intravenous fluid from said supply source; and a secondproximal end in the form of an entry site to facilitate injection ofsaid medicinal fluid into said second fitting via said needle.
 5. In aninfusion system to deliver intravenous fluid from a supply source to aninfusion site via a fluid line including a heat transfer unit includingfirst and second conduits, wherein said first conduit receives saidintravenous fluid and said second conduit receives heat transfer fluidto heat said intravenous fluid, and a fluid connector assembly tofacilitate fluid flow between said supply source and said heat transferunit, a method of injecting medicinal fluid into said fluid line whilemaintaining sterility of said intravenous fluid comprising: (a)receiving said intravenous fluid from said supply source within afitting of said fluid connector assembly and directing said intravenousfluid received by said fitting from said supply source into said heattransfer unit, wherein said fitting includes a housing structureincluding an elongated tubular body with a proximal end portion, a fluidinlet member with a distal end directly attached to said elongatedtubular body and a proximal end to receive intravenous fluid into saidhousing structure, and a fluid outlet disposed at a distal end of saidelongated tubular body and secured to said heat transfer unit with saidfluid outlet in fluid communication with said first conduit, whereinsaid proximal end portion of said elongated tubular body includes aninstrument member positioned within a proximal portion of said elongatedtubular body and an extension member extending proximally from saidinstrument member and forming a proximal end of said elongated tubularbody, and wherein said instrument member includes a membrane to maintaina fluid tight seal and permit removable insertion of a portion of aninstrument through said membrane and within said fluid connectorassembly; (b) receiving said instrument portion within said instrumentmember to facilitate injection of a medicinal fluid different than saidintravenous fluid into said fluid connector assembly, wherein saidinstrument includes a syringe containing said medicinal fluid and saidinstrument portion includes a needle with a length dimension; and (c)engaging a syringe distal portion via said extension member anddisplacing said syringe from said instrument member and providing adistance from said conduits greater than said length dimension of saidneedle to prevent contact and rupture of said conduits by said needleduring said injection.
 6. The method of claim 5, wherein step (c)further includes: (c.1) engaging said syringe distal portion, via saidextension member disposed proximate said membrane, and displacing thatportion from said membrane to limit insertion of said needle into saidfluid connector assembly.
 7. The method of claim 6, wherein saidextension member includes a length dimension in the approximate range of0.5 to 1.0 inches, and step (c.1) further includes: (c.1.1) displacingsaid needle from said conduits by restricting insertion of said needleinto said instrument member via said extension member.
 8. The method ofclaim 5, wherein said fluid connector assembly further includes a secondfitting including a distal end in fluid communication with said fluidinlet member, a second fluid inlet member disposed at a proximal end ofsaid second fitting to receive intravenous fluid, and a second proximalend in the form of an entry site to facilitate injection of saidmedicinal fluid into said second fitting via said needle, and step (c)further includes: (c.1) displacing said received needle from saidconduits by receiving said needle within said entry site of said secondfitting.
 9. An infusion system to deliver intravenous fluid from asupply source to an infusion site via a fluid line and to enableinjection of medicinal fluid into said fluid line while maintainingsterility of said intravenous fluid, said system comprising: heatingmeans for heating said intravenous fluid and including first and secondconduits, wherein said first conduit receives said intravenous fluid andis connected with a fluid line portion extending toward said infusionsite and said second conduit receives heat transfer fluid to heat saidintravenous fluid flowing through said first conduit; and fluidconnection means for facilitating fluid flow between said supply sourceand said heating means and including: flow means including a housingstructure for receiving said intravenous fluid and directing saidintravenous fluid received by said flow means into said heating means,wherein said housing structure includes: an elongated tubular bodyincluding a proximal end portion; fluid inlet means with a distal enddirectly attached to said elongated tubular body and a proximal end toreceive intravenous fluid into said housing structure; and fluid outletmeans disposed at a distal end of said elongated tubular body andsecured to said heating means with said fluid outlet means in fluidcommunication with said first conduit; wherein said proximal end portionof said elongated tubular body includes: instrument means positionedwithin a proximal portion of said elongated tubular body, wherein saidinstrument means includes a membrane to maintain a fluid tight seal andpermit removable insertion of a portion of an instrument through saidmembrane and within said fluid connection means, wherein said instrumentincludes a syringe containing a medicinal fluid and said instrumentportion includes a needle with a length dimension, and wherein saidsyringe facilitates injection of a medicinal fluid different than saidintravenous fluid into said fluid connection means; and extension meansextending proximally from said instrument means and forming a proximalend of said elongated tubular body, wherein said extension means isconfigured to engage a syringe distal portion and enable insertion ofsaid needle within said extension means, and wherein said extensionmeans displaces said syringe from said instrument means and provides adistance from said conduits greater than said length dimension of saidneedle to prevent contact and rupture of said conduits by said needleduring said injection.
 10. The system of claim 9, wherein said extensionmeans is disposed proximate said membrane and configured to engage saidsyringe distal portion and displace that portion from said membrane torestrict insertion of said needle into said fluid connection means. 11.The system of claim 10, wherein said extension means includes a lengthdimension in the approximate range of 0.5 to 1.0 inches to distance saidneedle from said conduits and restrict insertion of said needle intosaid instrument means.
 12. The system of claim 9, wherein said fluidconnection means further includes: second flow means including: a distalend in fluid communication with said fluid inlet means; second fluidinlet means disposed at a proximal end of said second flow means toreceive said intravenous fluid from said supply source; and a secondproximal end in the form of an entry site to facilitate injection ofsaid medicinal fluid into said second flow means via said needle.